Effects of Peginterferon Consolidation Therapy on Hepatic cccDNA Dynamics in CHB Patients Achieving Clinical Cure.

Not Applicable

Not yet recruiting

• Conditions: Chronic Hepatitis b
• Interventions: Drug: Peginterferon α-2b based injection

• Registration Number: NCT06920329
• Lead Sponsor: Xiamen Hospital of Traditional Chinese Medicine

Brief Summary

This is a single-center, prospective, exploratory clinical study. The study plans to enroll 30 chronic hepatitis B (CHB) patients which achieved HBsAg clearance based peginterferon α-2b treatment. Eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for HBV recurrence. Patients will be followed up every 12 weeks. The study will evaluate changes in intrahepatic covalently closed circular DNA (cccDNA) and peripheral blood HBV pregenomic RNA (pgRNA) levels after achieving HBsAg clearance.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-02
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-04-20
• Primary Completion: 2027-12-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form;
• Aged 18-65 years (inclusive), no gender restriction;
• A history of HBsAg positivity for at least 6 months or other evidence suggesting chronic hepatitis B;
• First observed clinical cure after treatment with peginterferon α-2b (PegIntron®), either as monotherapy or in combination with NAs, defined as serum HBsAg negative (<0.05IU/ml), HBV DNA undetectable (HBV DNA<20IU/ml), and HBeAg negative, within a 4-week window from the first observed day of clinical cure at the time of screening;
• Agreement to undergo two liver biopsies during the study;
• Negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period.

Exclusion Criteria

• Lactating women;
• Evidence of acute severe liver injury: such as ALT > 10 ULN, or significantly elevated ALT with significantly elevated bilirubin;
• Evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis;
• Evidence of hepatocellular carcinoma;
• Prothrombin time (PT) or INR > ULN;
• Participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peginterferon α-2b based group	Peginterferon α-2b based injection	-

Primary Outcome Measures

Name	Time	Method
Changes in intrahepatic cccDNA and peripheral blood pgRNA levels	baseline to week48
Clearance rate of intrahepatic cccDNA	week48

Secondary Outcome Measures

Name	Time	Method
Correlation between changes in intrahepatic cccDNA levels and interferon consolidation therapy	baseline to week48
Correlation between intrahepatic cccDNA clearance and interferon consolidation therapy	week48
intrahepatic HBsAg clearance rate	baseline、week48
Correlation between changes in peripheral blood pgRNA levels and interferon consolidation therapy	baseline to week48
Adverse Event#AE#	baseline to week48
Changes in intrahepatic cccDNA levels	baseline to week48
Histopathological scores in hepatic inflammation and fibrosis	baseline、week48
Recurrence rate	baseline to week48
Changes in intrahepatic HBsAg levels	baseline to week48

Trial Locations

Locations (1)

Xiamen Hospital of Traditional Chinese Medicine; 🇨🇳 Xiamen, Fujian, China